Responsibilities

You motivate, guide and support the QA Project Specialist and RA CMC Specialist team. You ensure regular evaluation and development of the team.
You prepare and provide regular feedback on operational performance within projects (reporting and KPIs).
You align yourself with the Project Managers of the development teams to identify quality and regulatory requirements and product acceptance criteria.
You actively participate in project reviews (RPC and RPS) and centralize follow-up for the team.
You organize, plan and ensure the efficient implementation of QA and RA tasks related to projects.
As soon as projects are drawn up, you are responsible for monitoring and drawing up documents relating to quality processes (QAA, specifications, protocols, stability plan, technical documents, preparation of CMC files, etc.).
You ensure the completion of Quality Events in connection with projects.
You ensure that regulatory files are maintained and distributed.
You are the quality reference and coordinate responses to specific customer requests.
You will be responsible for monitoring regulatory compliance with GMP and radiopharmaceutical requirements.
You take part in customer audits and ensure follow-up action.
You take part in drafting Product Quality Reviews (PQR).

Profile

You have a Master’s degree with a scientific orientation, or equivalent through experience.
You have at least 3 years’ experience in a similar position.
You have solid experience in a QA role with a broad vision of regulatory and quality requirements.
Expertise in the radiopharmaceutical sector is a plus.
You have experience in cross-functional management and project management.
You have experience in risk management.
You have a good knowledge and command of GMP/ICH standards.
You have a good command of English and French.
You have experience of managing deviations, changes, OOS, CAPA.
You are familiar with project tracking tools and MS Office.

Do you want to become a major player in the global fight against cancer?

At Trasis, we give you the opportunity to work with cutting-edge technologies and to contribute to the improvement of cancer diagnosis and therapy techniques. Through your actions, you will have the opportunity to have a positive impact on the services provided to users and patients.

The opportunity to participate in building and improving processes in a growing company.

We offer a young and friendly work atmosphere, a flexible and dynamic environment.

An attractive and flexible salary according to your experience and performance, with extra-legal benefits.

QA CMC Project Manager

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